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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group study to investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome (AEGIS – II Study).

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

CSL112_3001

Background Information

CSL112 is indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in acute coronary syndrome (ACS) patients diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and exclusive of unstable angina, including those managed with percutaneous coronary intervention or medically managed.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Christopher Defilippi, MD

Eligibility Information

  • Capable of providing written informed consent and willing and able to adhere to all protocol requirements
  • Male or female at least 18 years of age
  • Evidence of myocardial necrosis in a clinical setting
  • No suspicion of acute kidney injury at least 12 hours after IV contrast agent administration or after first medical contact for the index MI. There must be documented evidence of stable renal function
  • Evidence of multivessel coronary artery disease
  • At least 1 of the following established risk factors:
    • Age ≥ 65 years
    • Prior history of MI
    • On pharmacological treatment for diabetes mellitus
    • Peripheral arterial disease

Ineligibility Information

  • Ongoing hemodynamic instability
  • Evidence of hepatobiliary disease
  • Evidence of severe chronic kidney disease with an estimated glomerular filtration rate of < 30 mL/min/1.73 m2
  • Plan to undergo scheduled coronary artery bypass graft surgery after randomization
  • Body weight < 50 kg
  • Known history of allergies as follows:
    • Allergy to soy bean or peanuts
    • Known or suspected hypersensitivity to the investigational product
    • A known history of IgA deficiency or antibodies to IgA
  • Comorbid condition with an estimated life expectancy of ≤ 6 months
  • Women who are pregnant or breastfeeding at the time of randomization
  • Participated in another interventional clinical study within 30 days of consent
  • Known alcohol, drug, or medication abuse within 1 year before consent to this study
  • Treatment with anticancer therapy within 3 months before the first administration of investigational product
  • Previously randomized or participated in this study or previously exposed to CSL112
  • Mental condition rendering the subject unable to understand the nature of the study
  • Subjects who are incarcerated
  • Inability or unwillingness to comply with all follow-up through end of the study
  • Investigator determines that the subject is not suitable for study